A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY) (NEOFIX)

August 10, 2026 updated by: Nurami Medical Ltd
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Pre-operative inclusion criteria:

  1. Male or female aged ≥18 and <80 years.
  2. Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
  3. Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
  4. Surgical wound is expected to be Class I/clean.

  5. Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.

    Intra-operative Inclusion criteria:

  6. CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.
  7. The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.

Exclusion Criteria:

Pre-operative exclusion criteria:

  1. Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
  2. Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
  3. Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
  4. Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
  5. Subject had a previous surgery in the same anatomical site.
  6. Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.
  7. Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).
  8. Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.
  9. Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, or positive blood culture.
  10. Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).
  11. Subjected is diagnosed with sepsis, or systemic collagen disease.
  12. Subject at high risk of delayed or failed wound healing due to past treatments or conditions.
  13. Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels >1.3 mg/dL.
  14. Subject was diagnosed with liver disease evident by any of the following test results: ALT > 55 U/L, AST > 48 U/L, ALP > 129 U/L, GGT > 61 U/L, Total bilirubin > 1.3 mg/dL, Albumin < 3.5 g/Dl, INR > 1.2, or PT > 15 sec.
  15. Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c > 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.
  16. Subject had chemotherapy and/or radiotherapy in the past 8 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 8 weeks after surgery.
  17. Subject requires an external ventricular or lumbar CSF drain that must be left in place after surgery.
  18. Subject has congenital or acquired coagulopathy.
  19. The subject was classified as exhibiting drug abuse.
  20. Subject has any condition that, in the Principal Investigator's judgment, may compromise the subject's safety or preclude compliance with the study investigation plan and/or device instructions.
  21. Subject is participating in another clinical trial that tests any other drug or device.
  22. Subject is pregnant or breast-feeding at screening or intends to become pregnant during the study period.

  23. Subject has known history of sensitivity or allergy to any component of the ArtiFix®.

    Intra-operative Exclusion criteria:

  24. Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of care treatment
Device: Standard of Care (Investigator Choice)
Standard-of-care for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used)
Experimental: ArtiFix the investigational device
Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
ArtiFix® is a sterile, synthetic, single use, adhesive, resorbable sealant graft intended to seal and repair dural defects following cranial or spinal surgeries.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Time Frame: at 120 days after ArtiFix® or control implantation
at 120 days after ArtiFix® or control implantation
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Time Frame: at 120 days after ArtiFix® implantation.
at 120 days after ArtiFix® implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nurami Medical Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joseph Milbaum, MD, Nurami Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLN-0000265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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